Breast CancerCanEXNCT04679090
Physical Activity Levels and Functional Improvement in Breast Cancer Survivors
A study testing Exercise Program in people with Breast Cancer, run by University of New Brunswick at 3 sites in Canada.
Trial summary
The main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- 11 Sep 2018to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have received a diagnosis of breast cancer in your lifetime
- 19 years of age and older
- Cleared by medical team to participate in the study
- Have the intention to exercise at the facility for the duration of the study
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
University of Prince Edward Island
Charlottetown, Prince Edward Island
Travis Saunders, 9025660641, trsaunders@upei.ca
- Recruiting
University of New Brunswick
Fredericton, New Brunswick
Danielle Bouchard, 5064433908, dboucha1@unb.ca
- Recruiting
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador
Erin McGowan, 7098647269, emcgowan@mun.ca
About this study
Official title: Do Physical Activity Levels Predict Functional Improvements Following a Structured Exercise Program for Women Living With Breast Cancer?
The main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for six minutes.
Read the detailed description
The main research objective is to investigate the relationship between baseline physical activity and improvement in physical function, quantified using changes in 6-minute walk test (6MWT) results over the course of the 12-week program. An association is hypothesized to exist between the two variables even when adjusted for weeks into treatment. The goal of the 6MWT is to cover as much distance as possible in six minutes, using as many breaks s necessary. The test is often performed using a 20-meter hallway but requires no specific equipment. A recent study reported that the result of the 6MWT could be used as a measure of the major components of global health in women with breast cancer, making its use in our research especially relevant. Aside from physical functions, baseline characteristics will also be used to determine what characteristics, if any, are associated with health and psychosocial outcomes such as quality of life, social connectedness/support, and mental well-being. The data collected is certain to fill a gap in the literature, and will therefore be likely published in an important journal in the field.
- Conditions
- Breast Cancer
- Being tested
- Exercise Program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
Participants will exercise twice a week for twelve weeks total.
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | Participants will answer a series of questionnaires, wear a physical activity tracker (pedometer) and do functional tests (six minute walk test, chair stand test, balance, back scratch, sit and reach, leg strength and hand strength) pre and post. Receives: Other: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
6-minute walk test (meters walked)
Measured: Pre and post (after 12 weeks)
Balance
One leg stand test (seconds)
Measured: Pre and post (after 12 weeks)
Strength, Hand grip
Amount of force that can be exerted during grip squeeze (kg)
Measured: Pre and post (after 12 weeks)
Strength, Chair stand test
Chair stand test, number of chair stand in 30 seconds
Measured: Pre and post (after 12 weeks)
Flexibility, back scratch test
Back scratch test (cm)
Measured: Pre and post (after 12 weeks)
Flexibility, sit and reach
Sit and reach test
Measured: Pre and post (after 12 weeks)
Physical Activity Level
Pedometer to determine minutes in moderate-vigorous physical activity and steps per day
Measured: Pre and post (after 12 weeks)
Secondary outcomes (14)
Attendance
Amount of exercise sessions attended during the 12-week program
Measured: Pre and post (after 12 weeks)
Weight
Weight of individual (kg)
Measured: Pre and post (after 12 weeks)
Height
Height of individual (cm)
Measured: Pre and post (after 12 weeks)
Resting Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Measured: Pre and post (after 12 weeks)
Resting Heart Rate
Resting heart rate (beats per minute)
Measured: Pre and post (after 12 weeks)
Body-mass Index
Measure of body fat based on height and weight (kg/m^2)
Measured: Pre and post (after 12 weeks)
Waist Circumference
Measurement around the waist (cm)
Measured: Pre and post (after 12 weeks)
FANTASTIC Lifestyle Checklist
Meaningful improvement above day-to-day variability on the 6MWT
Measured: Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy General (FACT - G)
27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being
Measured: Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy Fatigue (FACT - F)
40-item measure that assesses self-reported fatigue and its impact upon daily activities and function
Measured: Pre and post (after 12 weeks)
Depression Anxiety Stress Scales (DASS)
42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.
Measured: Pre and post (after 12 weeks)
Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire that assesses sleep quality over a 1-month time interval
Measured: Pre and post (after 12 weeks)
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Questionnaire used to identify self-reported leisure-time physical activity
Measured: Pre and post (after 12 weeks)
Age
Age (years)
Measured: Pre and post (after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start11 Sep 2018
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Ultramar, Quebec Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Danielle Bouchard, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679090
- Sponsor's protocol ID
- University Brunswick
- Acronym
- CanEX
- Status last verified
- Feb 2021
- First submitted
- 1 Dec 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Physical Activity Levels Predict Functional Improvements Following a Structured Exercise Program for Women Living With Breast Cancer?
- ClinicalTrials.gov ID
- NCT04679090
- Acronym / sponsor ID
- CanEX / University Brunswick
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Ultramar, Quebec Breast Cancer Foundation
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for six minutes.
Detailed description
The main research objective is to investigate the relationship between baseline physical activity and improvement in physical function, quantified using changes in 6-minute walk test (6MWT) results over the course of the 12-week program. An association is hypothesized to exist between the two variables even when adjusted for weeks into treatment. The goal of the 6MWT is to cover as much distance as possible in six minutes, using as many breaks s necessary. The test is often performed using a 20-meter hallway but requires no specific equipment. A recent study reported that the result of the 6MWT could be used as a measure of the major components of global health in women with breast cancer, making its use in our research especially relevant. Aside from physical functions, baseline characteristics will also be used to determine what characteristics, if any, are associated with health and psychosocial outcomes such as quality of life, social connectedness/support, and mental well-being. The data collected is certain to fill a gap in the literature, and will therefore be likely published in an important journal in the field.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Other: Exercise ProgramParticipants will answer a series of questionnaires, wear a physical activity tracker (pedometer) and do functional tests (six minute walk test, chair stand test, balance, back scratch, sit and reach, leg strength and hand strength) pre and post. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have received a diagnosis of breast cancer in your lifetime
- 19 years of age and older
- Cleared by medical team to participate in the study
- Have the intention to exercise at the facility for the duration of the study
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramParticipants will exercise twice a week for twelve weeks total. | Other | Participant |
Primary outcome
Walking speed
Time frame: Pre and post (after 12 weeks)
6-minute walk test (meters walked)
Balance
Time frame: Pre and post (after 12 weeks)
One leg stand test (seconds)
Strength, Hand grip
Time frame: Pre and post (after 12 weeks)
Amount of force that can be exerted during grip squeeze (kg)
Strength, Chair stand test
Time frame: Pre and post (after 12 weeks)
Chair stand test, number of chair stand in 30 seconds
Flexibility, back scratch test
Time frame: Pre and post (after 12 weeks)
Back scratch test (cm)
Flexibility, sit and reach
Time frame: Pre and post (after 12 weeks)
Sit and reach test
Physical Activity Level
Time frame: Pre and post (after 12 weeks)
Pedometer to determine minutes in moderate-vigorous physical activity and steps per day
14 secondary outcomes
Attendance
Time frame: Pre and post (after 12 weeks)
Weight
Time frame: Pre and post (after 12 weeks)
Height
Time frame: Pre and post (after 12 weeks)
Resting Blood Pressure
Time frame: Pre and post (after 12 weeks)
Resting Heart Rate
Time frame: Pre and post (after 12 weeks)
Body-mass Index
Time frame: Pre and post (after 12 weeks)
Waist Circumference
Time frame: Pre and post (after 12 weeks)
FANTASTIC Lifestyle Checklist
Time frame: Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy General (FACT - G)
Time frame: Pre and post (after 12 weeks)
Functional Assessment of Cancer Therapy Fatigue (FACT - F)
Time frame: Pre and post (after 12 weeks)
Depression Anxiety Stress Scales (DASS)
Time frame: Pre and post (after 12 weeks)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre and post (after 12 weeks)
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Time frame: Pre and post (after 12 weeks)
Age
Time frame: Pre and post (after 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Bouchard principal investigator
University of New Brunswick
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Breast Cancer, run by University of New Brunswick at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Bouchard (5064433908, dboucha1@unb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Pre and post (after 12 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.